Panel warns on vaccine trial consent

Feb 13, 2011 - Rashme Sehgal |

Age Correspondent

New Delhi

A three-member team comprising S.S. Agarwal, former director of Sanjay Gandhi PGI of Medical Sciences, Lucknow, S.P. Agarwal, former director-general of health services and Suneeta Mitta from AIIMS took the Andhra Pradesh government health authorities to task for having permitted hostel wardens and headmasters to sign consent forms on behalf of minor girls belonging to tribal communities in the PATH-ICMR study using the human papillomavirus (HPV) in India.

It castigated such a trend and warned that all states should desist from this, except in cases where the tribal population directly benefited from such projects. The members also question the fact that the “vaccine for the study was being provided by the manufacturers free of cost”. This raised concerns about “undeclared conflict of interest” since the results of the study may be used to influence the decision by the government, the report stated. Activists had raised the issue of conflict of interest since the PATH was being funded for this exercise by the Bill and Melinda Gates Foundation, which had a substantial share in Merck which was manufacturing the cancer vaccine used in this study.
The report warned that this vaccination should be viewed as a supplement to cervical cancer screening and not to replace such a programme. The women’s organisation Saheli, in a rejoinder to the report, wondered why Khamam district had been selected since not a single screening facility existed in this district.
The demonstration project was being jointly carried out by PATH in collaboration with the Indian Council of Medical Research in both Andhra Pradesh and Gujarat since 2007. Twenty-four thousand girls were being used in this study which the ministry of health had been forced to suspend in 2010 following reports of the deaths of seven tribal girls.
The enquiry panel has also commented on the failure of the project to systematically administer these three vaccine doses with some girls having received only one dose against the mandatory three doses.

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